Pharmaceutical clinical trials (often referred to as “studies” in the pharmaceutical industry) play an important role in drug developments, because clinical trials are used to collect safety and efficacy data of drug candidates (e.g., small molecules, biologics, and combination devices). In some instances, pharmaceutical companies can spend over $100 million to conduct a clinical trial. Safety and efficacy data from clinical trials, and sometimes even communications to and from clinical trial investigators (also called principal investigators) and other documents need to be recorded accurately and maintained pursuant to government regulations in order for the drug candidates to obtain regulatory approval by government agencies.
Many clinical trial documents require signatures, for example, of clinical trial investigators or patients. Hardcopy documents (e.g., documents printed on paper), rather than softcopy documents (e.g., electronic documents), are frequently used in clinical trials for various reasons (e.g., ease to prove authenticity and integrity). However, tracking and maintaining all regulatory documents throughout clinical trials, some of which may last over years, is not an easy task. The cost of losing key clinical trial documents can be significant because it may render data from a multi-year clinical trial useless or in want of an expensive follow-up clinical trial. Therefore, there is a need for a better system and method for managing and sharing pharmaceutical clinical trial regulatory documents.